This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.
Medicine, Chinese Traditional/methods* ; Tongue ; Image Processing, Computer-Assisted ; Diagnostic Equipment ; Reference Standards

In order to detect freezing of gait of Parkinson's patients automatically, a system based on inertial measurement unit to detect freezing of gait for Parkinson's patients is established. The two inertial measurement units are respectively fixed on the left and right ankles of the patient to be measured, the freezing index is calculated by windowed Fourier transform, the freezing threshold is calculated based on the freezing index during normal walking, and the freezing index and the freezing threshold are compared to complete the detection of freezing of gait. The experimental results show that the number of freezing of gait occurrences in Parkinson's patients is accurately detected, and it has high sensitivity and specificity, which can assist doctors to objectively assess the patient's condition.
Diagnostic Equipment ; standards ; Gait Disorders, Neurologic ; diagnosis ; etiology ; Humans ; Parkinson Disease ; complications ; Sensitivity and Specificity ; Walking

In order to improve the quality of medical equipment after-sales service quality and improve the quality of medical equipment maintenance, this paper discusses the establishment of an evaluation index system to evaluate the quality of ultrasonic diagnostic equipment. From the three aspects of maintenance results, maintenance process and maintenance coverage, the quality of the post-maintenance quality of hospital ultrasound diagnostic equipment manufacturers is objectively evaluated.
Commerce ; Diagnostic Equipment ; Equipment and Supplies, Hospital ; Maintenance ; Materials Management, Hospital

OBJECTIVE: To improve the monitoring mode of diagnostic medical devices adverse events. METHODS: By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified. RESULTS: The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated. CONCLUSIONS The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.
China ; Equipment and Supplies ; Reagent Kits, Diagnostic ; Risk Management

OBJECTIVE: To establish a cone beam computed tomography (ECBCT) system for high-resolution imaging of the extremities. METHODS: Based on three-dimensional X-Ray CT imaging and high-resolution flat plate detector technique, we constructed a physical model and a geometric model for ECBCT imaging, optimized the geometric calibration and image reconstruction methods, and established the scanner system. In the experiments, the pencil vase phantom, image quality (IQ) phantom and a swine feet were scanned using this imaging system to evaluate its effectiveness and stability. RESULTS: On the reconstructed image of the pencil vase phantom, the edges were well preserved with geometric calibrated parameters and no aliasing artifacts were observed. The reconstructed images of the IQ phantom showed a uniform distribution of the CT number, and the noise power spectra were stable in multiple scanning under the same condition. The reconstructed images of the swine feet had clearly displayed the bones with a good resolution. CONCLUSIONS The ECBCT system can be used for highresolution imaging of the extremities to provide important imaging information to assist in the diagnosis of bone diseases.
Algorithms ; Animals ; Artifacts ; Calibration ; Cone-Beam Computed Tomography ; instrumentation ; methods ; Equipment Design ; Extremities ; diagnostic imaging ; Image Processing, Computer-Assisted ; methods ; Phantoms, Imaging ; Radiographic Image Enhancement ; instrumentation ; methods ; Swine

Arthroscopy ; adverse effects ; instrumentation ; methods ; Diagnostic Equipment ; adverse effects ; microbiology ; Disinfection ; methods ; Equipment Failure ; Humans ; Materials Testing ; methods ; Orthopedic Equipment ; adverse effects ; microbiology ; Postoperative Complications ; etiology ; prevention & control

OBJECTIVE: To compare the quality of tissue from punch biopsy forceps (PB group) with round loop electrode (LE group) in colposcopically directed biopsy along with the evaluation of pain associated with each procedure. METHODS: Patients with abnormal cervical cytologic results and abnormal colposcopic findings were enrolled into a randomized trial into either a PB group or LE group. The quality of tissue was evaluated in regards to the size of tissue, site of tissue, and tissue damage. Each quality had 1 to 3 points and the sum of each quality contributed to the total tissue score that ranged from 3 to 9. Pain associated with each procedure was assessed by a visual analog scale (VAS). This was a clinical trial study and was registered at www.clinicaltrials.in.th (Identifier: TCTR20160404001). RESULTS: Ninety-six women who met all eligibility requirements were enrolled in the study. Forty-eight patients were randomly assigned to the PB group and 48 patients were randomized into the LE group. The characteristics of the patients were similar between the 2 groups with the exception of the median age. The median total tissue score was 8 points in the LE group which was more than the median of 7 points in the PB group with a statistically significant difference (p=0.014). However, the median VAS pain score in both groups was 3.4 (p=0.82). CONCLUSION: The quality of cervical tissues obtained from biopsy with a round loop electrode was better than the punch biopsy forceps with no difference in the level of pain.
Biopsy* ; Cervix Uteri ; Colposcopy ; Diagnostic Equipment ; Electrodes* ; Female ; Humans ; Surgical Instruments* ; Visual Analog Scale

To assess the application of Keratograph 5M in evaluating tear film and meibomian gland function in patients with dry eye.A total of 144 eyes were recruited in the study, in which 72 eyes were from patients diagnosed with dry eye and 72 eyes were from healthy subjects. All subjects finished following tests or examinations:ocular surface disease index (OSDI) to evaluate eye symptoms; Keratograph 5M examination to obtain tear meniscus height (TMH), noninvasive tear break-up time (NIBUT) including first NIBUT (NIBUT-Fir) and average NIBUT (NIBUT-Ave), and infrared meibography; and fluorescein sodium staining to obtain fluorescein tearbreak-up time (FBUT).Dry eye group had higher OSDI score than healthy control group, but its TMH, NIBUT-Fir and NIBUT-Ave were lower than those in healthy control group (all<0.01). Total meiboscore in dry eye group was higher than that in healthy control group (<0.01), and it showed a significant correlation with NIBUT-Fir and NIBUT-Ave (=-0.449 and -0.398,<0.01), but no correlation with ages was observed (=0.031,>0.05). The NIBUT-Fir and NIBUT-Ave showed a significant correlation with FBUT (=0.833 and 0.727,<0.01).Keratograph 5M is a convenient, accurate and non-invasive method to assess the function of tear film and meibomian gland, and the new meibography scoring system can evaluate the function of meibomian gland objectively and succinctly.
Corneal Topography ; instrumentation ; Diagnostic Equipment ; Dry Eye Syndromes ; diagnostic imaging ; Female ; Humans ; Male ; Meibomian Glands ; diagnostic imaging ; Tears ; diagnostic imaging

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.
Agriculture ; Animals ; Certification ; Classification ; Equipment and Supplies ; Indicators and Reagents ; Insemination, Artificial ; Japan ; Korea ; Plants ; Quarantine ; Reagent Kits, Diagnostic

This paper mainly introduces the material composition and structure of two kinds of compound tabletop which currently used in large medical imaging equipment, also introduces the proper material choosing and production processing, together with the advantage and shortage of this two kinds of tabletop and different application occasion.
Construction Materials ; Diagnostic Imaging ; instrumentation ; Durable Medical Equipment